Cpap at Delivery Room for Preterm Infants (CPAP-DR)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2009 by University of Sao Paulo. Recruitment status was: Active, not recruiting

Sponsor:

University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01024361

First Posted: December 2, 2009

Last Update Posted: December 23, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Infants randomized to this arm will have nasal CPAP installation at delivery room before the 15th minute of life

Device: CPAP

CPAP of 5 cm water pressure will be applied within 15 minutes after birth by Neopuff

Other Name: Neopuff

Detailed Description:

A multicenter prospective cohort of inborn preterm infants, born at 8 public university NICU in Brazil, with birthweight 1000-1499 g, without malformations, not intubated at 15 minutes of life. Preterm infants will be randomly assigned at birth to an early treatment group (DR-CPAP), in which CPAP of 5 cm water pressure is applied within 15 minutes after birth by Neopuff, or to a routine group (RG), in which CPAP is applied when indicated by the assistant physician. After transfer to the NICU, nasal CPAP will be maintained with Hudson prongs

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

up to 15 Minutes (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:Inborn.

Birth weight 1000g to 1500g

No major malformations

Exclusion Criteria:

Necessity of intubation

Maternal decision

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024361